Words by Isabel O’Brien
The FDA has approved Roche’s new subcutaneous formulation of ocrelizumab for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This approval marks a pivotal moment in MS care, offering a new option for patients who require a more flexible treatment solution, while addressing growing infrastructure challenges within healthcare systems.
The twice-a-year injection provides an alternative to the intravenous (IV) form of the drug, potentially expanding access to MS treatment for patients who do not have reliable access to infusion centres. As healthcare professionals face increasing pressure to manage both patient load and clinic resources, this new formulation allows MS care to be more easily integrated into smaller clinics or general practice settings.
The approval was based on robust data from the Phase III OCARINA II trial, which demonstrated the subcutaneous formulation offers comparable efficacy and safety to the existing IV option. This provides reassurance to both clinicians and patients that the same level of disease control can be achieved.
The development of this new formulation is a direct response to the growing demand for greater flexibility in managing chronic diseases like multiple sclerosis. Natalie Blake, Executive Director, The MS Foundation, reinforced the impact of this shift. “It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential,” she said.
This is just the latest development in Roche’s commitment to understanding and treating multiple sclerosis. The company is investing heavily in bringing patient-focused, scalable solutions to market and in research aimed at reducing the progression of disability in both RMS and PPMS.
